NCT07139756Not yet recruiting
Deciphering the Mechanisms of Central BP Regulation in Patients With PD Associated With Orthostatic Hypotension
Deciphering the Mechanisms of Central Blood Pressure Regulation in Patients With Parkinson Disease Associated With Orthostatic Hypotension: A 2-phase Observational Study With Healthy Participants and Patients With Parkinson's Disease
Source: ClinicalTrials.gov · Last updated 24 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Phase 1 objective: test the feasibility of using a 3Tesla MRI scanner instead of a 7Tesla MRI scanner to measure brainstem responses to LBNP in healthy participants. Phase 2 primary objective: compare the brainstem responses to LBNP in patients with PD associated with OH to PD patients without OH using BOLD fMRI
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 130 (estimated)
- First submitted
- 18 Aug 2025
- Start date
- 1 Oct 2025
- Primary completion date
- 30 Sept 2027
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Diseases
- Parkinson disease
- NCT number
- NCT07139756
What you commit to
- Study type: Observational
- Planned participants: 130
- From 1 Oct 2025 to the primary completion date, 30 Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any medication (acute or chronic prescription) except oral contraception
- Concomitant participation in a clinical trial
- Blood donation in the 60 previous days
- Blood donation in the previous 6 months
Other illness
- Chronic or acute illness
- Allergy to components of contrast agent Sonovue®
- Dementia
- Type 2 diabetes
- Stroke or myocardial infarction in the past 6 months
Lab values
- eGFR \< 45 ml/min/1.73 ml/min/m2 by CKD-EPI equation
Other
- Schellong test showing OH (drop of Systolic BP \>20 mmHg or Diastolic BP \>10 mmHg)
- Pregnant or lactating women
- Refusal to be informed of incidental findings
- Clinical significant abnormal blood test as assessed by the investigator
- Contra-indications for MRI
- Unable to follow study procedures
- Having a hierarchical relationship with the investigator or being family of the investigator
- Phase 2:
- Unable to give an informed consent
- BP \> 180/110 mmHg on 24-hour ambulatory blood pressure monitoring
- having contra-indications for MRI
- Pregnant or lactating women
- Refusal to be informed of incidental findings
- Living in an institution
- Active oncology treatment
- Having a hierarchical relationship with the investigator or being family of the investigator
Who the study is looking for
- Signed informed consent
- Age ≥ 18 years and \<75 years
- Normal office blood pressure (\<140/90 mmHg)
- For women of childbearing potential: using or willing to use during the study a reliable contraception method compatible with MRI
- Signed informed consent
- Fulfilling Movement Disorder Society clinical criteria for "clinically established PD"
- Age ≥18 years and \<75 years
- PD treated by dopamine replacement therapy (DRT)
- Willing and able to comply with the visit schedule and study procedures
- Autonomous in daily life
- Schellong test showing OH (drop of Systolic BP \>20 mmHg or Diastolic BP \>10 mmHg)(for study group with OH) or no OH (for studygroup without OH)
- For women of childbearing potential: using or willing to use during the study a reliable contraception method compatible with MRI
Criteria the registry did not label
- Phase 1:
Age in the registry: 18 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Hospitalier Universitaire Vaudois Coordinator of this site? Confirm its status | Lausanne | Switzerland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.